scholarly journals Effects of Perioperative Transcutaneous Electrical Acupoint Stimulation on Monocytic HLA-DR Expression in Patients undergoing Coronary Artery Bypass Grafting with Cardiopulmonary Bypass: Study Protocol for a Double-blind Randomized Controlled Trial

2019 ◽  
Author(s):  
Wen-ting Chen ◽  
Jin-feng Wei ◽  
Lan Wang ◽  
Deng-wen Zhang ◽  
Wei Tang ◽  
...  

Abstract Background: Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), even mortality. The effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture related techniques, such as electroacupuncture (EA) and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump Coronary Artery Bypass Grafting (CABG). Methods: This clinical study was a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into 2 groups: the group of TEAS, and the group of transcutaneous acupoint pseudo - electric stimulation (Sham TEAS). Monocytic HLA-DR expression serves as a primary endpoint, and other laboratory parameters (e.g. IL-6, IL-10) and clinical outcomes (e.g. postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group protein 1 (HMGB1) and regulatory T cell (Treg) will also be measured. Discussion: The current study is a preliminary mono-centric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large sample clinical trial with using relevant patient-centered clinical outcomes as primary endpoints.

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Wen-ting Chen ◽  
Jin-feng Wei ◽  
Lan Wang ◽  
Deng-wen Zhang ◽  
Wei Tang ◽  
...  

Abstract Background Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), and even mortality. Effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture-related techniques, such as electroacupuncture and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post-cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump coronary artery bypass grafting (CABG). Methods This study is a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into two groups: the group receiving TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS). Expression of mHLA-DR serves as a primary endpoint, and other laboratory parameters (e.g., interleukin [IL]-6, IL-10) and clinical outcomes (e.g., postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group box 1 protein and regulatory T cells will also be measured. Discussion The current study is a preliminary monocentric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large-sample clinical trials using relevant patient-centered clinical outcomes as primary endpoints. Trial registration ClinicalTrials.gov, NCT02933996. Registered on 13 October 2016.


2013 ◽  
Vol 66 (1-2) ◽  
pp. 64-69 ◽  
Author(s):  
Dragana Unic-Stojanovic ◽  
Miroslav Milicic ◽  
Petar Vukovic ◽  
Srdjan Babic ◽  
Miomir Jovic

Introduction. Patients on dialysis for end-stage renal failure are subjected to cardiac surgery with increasing frequency. End-stage renal failure is known to be an important risk factor for complications of cardiac operations performed with cardiopulmonary bypass. The aim of this study was to determine the impact of preoperative clinical status and operative variables on perioperative morbidity and mortality in hemodialysis dependent patients subjected to a cardiac surgery. Material and Methods. The following operative variables were examined: urgency, type and duration of surgery and duration of extracorporeal circulation. The study is a retrospective analysis of consecutive patients with end-stage renal failure dependent on maintenance hemodialysis who underwent cardiac surgery during four years. Results. The study included 46 patients. Operations performed included isolated coronary artery bypass grafting (CABG, n = 24), valve surgery alone (n = 6), and combined valve surgery or coronary artery bypass grafting and valve surgery (n = 16). The perioperative mortality rate was 13% with four fatal outcomes in patients who had undergone combined cardiac surgery. We found age > 70 years, preoperative New York Heart Association class IV, preoperative anemia, combined surgery and emergent surgery to be associated with a higher relative risk for perioperative death. Conclusion. Patients on dialysis have an increased morbidity and mortality following cardiac surgery; however, we believe that end-stage renal failure should not be regarded as a contraindication to cardiac surgery or cardiopulmonary bypass.


2019 ◽  
Author(s):  
Wen-ting Chen ◽  
Jin-feng Wei ◽  
Lan Wang ◽  
Deng-wen Zhang ◽  
Wei Tang ◽  
...  

Abstract Abstract Background: Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), even mortality. The effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture related techniques, such as electroacupuncture (EA) and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump CABG. Methods: This clinical study was a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB were randomized into 2 groups: the group of TEAS, and the group of transcutaneous acupoint pseudo - electric stimulation (Sham TEAS). Monocytic HLA-DR expression serves as a primary endpoint, and other laboratory parameters (e.g. IL-6, IL-10) and clinical outcomes (e.g. postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, some immune indicators, such as high mobility group protein 1 (HMGB1) and regulatory T cell (Treg), possibly related to the mechanism of TEAS, will also be measured. Discussion: The current study is a preliminary mono-centric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large sample clinical trial with using relevant patient-centered clinical outcomes as primary endpoints. Trial registration: This study was approved by Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine with the number 2016-455-06-01. The results of the trial will be published in an internationally peer-reviewed journal. This study was registered at ClinicalTrials with the Identifier NCT02933996 on 13 October 2016, https://www.clinicaltrials.gov/ct2/show/NCT02933996 Keywords: CABG; TEAS; immunosuppression; mHLA-DR


2002 ◽  
Vol 10 (4) ◽  
pp. 362-364 ◽  
Author(s):  
Calvin SH Ng ◽  
Ahmed A Arifi ◽  
Song Wan ◽  
Tak Wai Lee ◽  
Anthony PC Yim

Pulmonary tuberculosis reactivation is an unusual cause of respiratory failure after cardiac surgery. Fulminating tuberculosis was reactivated in a 50-year-old man after combined coronary artery bypass grafting and pulmonary resection on cardiopulmonary bypass. Clinicians should be aware of the immunosuppressive effects associated with cardiopulmonary bypass, and the consequent potential for tuberculosis reactivation.


2006 ◽  
Vol 104 (3) ◽  
pp. 458-465 ◽  
Author(s):  
Geoffrey G. Lockwood ◽  
Nicholas P. Franks ◽  
Neil A. Downie ◽  
Kenneth M. Taylor ◽  
Mervyn Maze

Background Postoperative neurocognitive deficit is prevalent after cardiac surgery. Xenon may prevent or ameliorate acute neuronal injury, but it also may aggravate injury during cardiac surgery by increasing bubble embolism. Before embarking on a randomized clinical trial to test the safety and efficacy of xenon for postoperative neurocognitive deficit, we undertook a phase I study to investigate the safety of administering xenon to patients undergoing coronary artery bypass grafting while on cardiopulmonary bypass and to assess the practicability of our xenon delivery system. Methods Sixteen patients scheduled for coronary artery bypass grafting surgery with hypothermic cardiopulmonary bypass gave their informed consent to participate in an open-label dose-escalation study (0, 20, 35, 50% xenon in oxygen and air). Xenon was delivered throughout surgery using both a standard anesthetic breathing circuit and the oxygenator. Gaseous and blood xenon partial pressures were measured five times before, during, and after cardiopulmonary bypass. Middle cerebral artery Doppler was used to assess embolic load, and major organ system function was assessed before and after surgery. Results Middle cerebral artery Doppler showed no evidence of increased emboli with xenon. Patients receiving xenon had no major organ dysfunction: Troponin I and S100beta levels tended to be lower in patients receiving xenon. Up to 25 l xenon was used per patient. Xenon partial pressure in the blood tracked the delivered concentration throughout. Conclusions Xenon was safely and efficiently delivered to coronary artery bypass grafting patients while on cardiopulmonary bypass. Prevention of nervous system injury by xenon should be tested in a large placebo-controlled, randomized clinical trial.


2013 ◽  
Vol 57 (7) ◽  
pp. 2996-3002 ◽  
Author(s):  
D. Hutschala ◽  
K. Skhirtladze ◽  
C. Kinstner ◽  
M. Zeitlinger ◽  
W. Wisser ◽  
...  

ABSTRACTThe use of cardiopulmonary bypass (CPB) during cardiac surgery causes regional ventilation-perfusion mismatch, contributing to regional disturbances in antibiotic penetration into lung tissue. Ventilation-perfusion mismatch is associated with postoperative pneumonia, a frequent and devastating complication after cardiac surgery. In this prospective clinical animal study, we performedin vivomicrodialysis to determine the effect of CPB on regional penetration of levofloxacin (LVX) into lung tissue. Six pigs underwent surgery with CPB (CPB group), and another six pigs underwent surgery without CPB (off-pump coronary artery bypass grafting; OPCAB group). LVX (750 mg) was administered intravenously to all pigs immediately after surgery. For regional measurements of LVX in pulmonary concentrations, microdialysis probes were inserted in both lungs of each pig. Pigs were placed in the right lateral position. Time versus concentration profiles of unbound LVX were measured in the upper and lower lung tissue and plasma in all pigs. In all pigs, maximum concentrations (Cmax) of LVX were significantly lower in the upper lung than in the lower lung (OPCAB,P= 0.035; CPB,P< 0.001). MedianCmaxof LVX showed a significant difference in the upper versus lower lung in the CPB group (P< 0.05). No significant difference was found in the medianCmaxof LVX in the upper and the lower lung in the OPCAB group (P= 0.32). Our data indicate that CPB affects perioperative regional antibiotic penetration into lung tissue. Common clinical antibiotic dosing schemes should be reevaluated in patients undergoing coronary artery bypass grafting with CPB.


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